Axicabtagene Ciloleucel Approved for Relapsed/Refractory Follicular Lymphoma

The FDA has approved axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory indolent follicular lymphoma (FL) who have received two or more lines of systemic therapy.

This decision is based on data from the ZUMA-5 trial, in which 91% of patients with relapsed or refractory FL (n=81) responded to the chimeric antigen receptor (CAR) T-cell therapy. At a median follow-up of 14.5 months, the median duration of response among trial participants had not been reached. An estimated 74% of patients were reported to be in remission at 18 months of follow-up.

Grade ≥3 cytokine release syndrome occurred in 8% of patients, and neurologic toxicities were reported in 21% of patients. The most common grade ≥3 AEs, occurring in ≥10% of patients, included febrile neutropenia, encephalopathy, and infection.

“Once a follicular lymphoma patient’s disease relapses, the duration of response to care shortens with each round of therapy,” said Caron A. Jacobson, MD, Medical Director of the Immune Effector Cell Therapy Program at the Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School. “Additionally, for [patients with FL] in the third line of therapy, the five-year survival rate is only 20%, highlighting the urgent need for treatments that offer a real chance for durable remission.” Based on these data, she added, axicabtagene ciloleucel gives “these patients much-needed hope and oncologists an important addition to the treatment armamentarium.”

Axicabtagene ciloleucel is the first CAR T-cell therapy to be approved for patients with indolent FL. In October 2017, it was granted approval for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Sources: Gilead press release, March 5, 2021; ClinicalTrials.gov NCT03105336.